Medical Devices Today

FDA Genetic Test Oversight Is On The Rise, But How Far Can It Go?

It looks increasingly likely that FDA will play a larger role in genetic test oversight, though policymakers may soon have to decide just how much more the agency can and should do.

"There is a major gap in the oversight of genetic tests when it comes to the evaluation of clinical validity. ... A truck can drive through that hole," says Reed V. Tuckson, M.D., chief of medical affairs at UnitedHealth Group and chair of a Department of Health and Human Services advisory panel tasked with drafting a better model for genetic test oversight. "We find that to be unacceptable and it needs to be fixed."

Industry and government agency reps are calling for FDA review of all diagnostic tests, including those developed by laboratories, and their proposals are increasingly attracting attention. Currently FDA does not regulate most lab-developed tests, or LDTs, sold as diagnostic services. The agency consistently regulates in vitro diagnostic test kits, sold as packaged products.

Industry Looks To FDA’s New Combo Products Chief For Answers

FDA's Office of Combination Products says it is getting back on track with new leadership in place after months of flux. Industry meanwhile is pushing the office to accelerate the release of rules and guidelines to help companies navigate the relatively new area of regulation.

Thinh Nguyen, who took over as director of the office Jan. 6, says his 14 years of experience at CDRH, where he was a key player in the premarket review office, will serve him well at OCP. "Most of the combination products have a device component," he said in a Feb. 13 interview with "The Gray Sheet."

Nguyen says he will work to "bridge the gaps" between different parts of the industry developing combination products. He will largely pick up where former director Mark Kramer left off on several key issues, he says. Kramer headed the office since it was formed by the 2002 device user fee legislation and departed for the private sector in April 2007.

Bush Budget Request Would Cut 10 Staff Positions At FDA Device Center

President Bush's Feb. 4 budget request asks for about $7 million in additional funds for FDA's device program in fiscal year 2009 compared to current levels, but would cut 10 full-time staff equivalents at CDRH.

The requested funds cover cost-of-living increases and a small bump in device import oversight spending. Device FTEs within the agency's Office of Regulatory Affairs field inspection branches would hold at 2008 levels (421 FTEs), but CDRH would go from 1,125 to 1,115 FTEs if the proposal were to become law.

Further, about $1.4 million in savings gained from "FDA modernization efforts" are being redirected away from CDRH to "higher level priorities," budget documents note.

"CDRH doesn't do so well in this budget," said Steven Grossman, a deputy executive director for the Alliance for a Stronger FDA, a consortium of former government employees and professional, patient and industry groups lobbying for more FDA funds. "Nobody does, but CDRH does particularly poorly."

CryoCor Sees Opportunity With A-Fib Ablation Label; Do Physicians Agree?

CryoCor hopes its lead in the race to gain an atrial fibrillation indication for an ablation catheter will translate into a market advantage, but first it will need to change what it says are misperceptions among some physicians about the limitations of cryoenergy.

In August, San Diego-based CryoCor became the first company to complete enrollment in a randomized pivotal trial for an ablation catheter to treat atrial fibrillation. After one-year follow-up is complete, the firm plans to submit a PMA in the latter part of 2008.

The CryoCor cryoablation system disrupts cardiac arrhythmias using extreme cold to create lesions in cardiac tissue. It was approved in August to treat atrial flutter (¹"The Gray Sheet" Aug. 6, 2007, p. 16).